MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEMORAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Model Number 2544-01-006

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Two of the 3 x 254401006 impactors has broken in half, the other impactor has a large piece missing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint #
=
> (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  corrected: h6 (device) removed the code for component missing.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE FEMORAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10555364
• MDR Text Key: 207584592
• Report Number: 1818910-2020-20492
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130222
• UDI-Public: 10603295130222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-01-006
• Device Catalogue Number: 254401006
• Device Lot Number: AU4790476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1